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Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Irvine, California, United States of America

Job Description:

Johnson & Johnson is recruiting for a Senior Director, BWI Quality & Compliance to support our Cardiac Electrophysiology business. The role is based in Irvine, CA.

POSITION SUMMARY

Head of Quality, responsible for ensuring effective implementation of BWI Quality Management System.

RESPONSIBILITIES

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Leads BWI Worldwide Quality functions, setting the strategies and goals in accordance with applicable regulatory requirements. Johnson and Johnson Enterprise, Medical Device and CSS policies and goals.
• Product Quality – Oversees directly and indirectly organization of Quality professionals, such as engineers and scientists that focus on quality aspects of development, lifecycle, supply chain, production and support. Includes partnership in new product development and leadership in supplier qualification, product release, field actions and complaint resolution activities.
• Quality Services – Leads effective establishment of organizations that support business process and compliance, quality risk management, design assurance, internal audits, corrective and preventive action, records management and document control, complaint management and medical device reporting and management of quality data across disciplines.
• Management Representative – Provides management with executive responsibility with objective evaluation of overall BWI Worldwide Quality performance and provides leadership and guidance for implementation of improvements, corrective and preventive actions.
• Act as a management Representative and Person Responsible for Regulatory Compliance (PRRC) for BWI US Sites according to 100753348.
• Quality Systems – Designated Management Representative for BWI.
• Partners with business and functional leaders to drive risk mitigation, proactive action and continuous improvement. Communicates and promotes Quality vision and goals.
• Recruits and retain high caliber Quality professionals.
• Perform other work-related duties as assigned by the manager of this role
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

QUALIFICATIONS

• Bachelor’s degree in Life Sciences or Engineering. A master’s degree is preferred.
• 12+ years of regulated device experience, with a minimum of 5 years in quality management or related functions.
• Experience with cardiac electrophysiology devices preferred.
• Excellent communication skills, both written and oral are required.
• Knowledge of relevant applicable standards and regulations for products and quality systems. Ability to interpret above standards and regulations and apply as an input to all company activities and management decisions.
• Ability to enroll and influence across functional areas is required.
• Strong collaboration and influence management skills to partner effectively with Sector functions and across Operating Units.
• Proven track record of demonstrating collaboration across the organization and at all levels
• Balanced technical understanding of products and processes combined with superior business and compliance acumen.
• Accountability, with a strong desire to commit, be held accountable and is rewarded for delivering results.
• Ability to recognize, build support for change and engage in constructive conflict.
• High tolerance for ambiguity in a complex environment.
• Ability to make the complex clear and easily understood by others.
• Able to generate enthusiasm for best-in-class performance through the clear personal passion. to be the best in these areas.
• Ability to build partnerships both internally and externally.

ROLE LOCATION: This role is in Irvine, CA and will be required to be on-site.

RELOCATION: Relocation will be provided to the right candidate.

SUPERVISORY RESPONSIBILITIES: Supervise Managers and individual contributors across multiple sites.

TRAVEL REQUIREMENTS: 0% - 30% travel required (Domestic or International)

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

173, 000 - 299, 000

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https: //www.careers.jnj.com/employee-benefits